1366TiP - Phase II study of erlotinib for previously treated non-small cell lung cancer patients without epidermal growth factor receptor mutation: Central Ja...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Masahiro Morise
Authors M. Morise1, H. Taniguchi2, H. Saka3, J. Shindoh4, R. Suzuki5, E. Kojima6, T. Hase1, M. Kondo1, H. Saito7, Y. Hasegawa8
  • 1Respiratory Medicine, Nagoya University Graduate School of Medicine, 466-8550 - Nagoya/JP
  • 2Department Of Respiratory Medicine And Allergy, Tosei General Hospital, Seto/JP
  • 3Medical Oncology & Respiratory Medicine, National Hospital Organization Nagoya Medical Center, 460-0001 - Nagoya/JP
  • 4Respiratory Medicine, Ogaki Municipal Hospital, Ogaki/JP
  • 5Respiratory Medicine, Toyohashi Municipal Hospital, Toyohashi/JP
  • 6Respiratory Medicine, Komaki Municipal Hospital, Komaki/JP
  • 7Respiratory Medicine, Aichi Cancer Center Aichi Hospital, 444-0011 - Okazaki/JP
  • 8Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya/JP



Erlotinib has been shown moderate activity for previously treated non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor (EGFR). However, the sensitivity of methods for detection of EGFR mutations can influence the efficacy of erlotinib. Moreover, it is controversial about association between K-ras mutations and erlotinib resistance in EGFR wild-type NSCLC. Here, we conducted a phase II study of erlotinib for previously treated NSCLC patients without EGFR mutation screened by PNA-LNA PCR clamp methods, which is known to be highly sensitive method for the detection of EGFR mutations. Furthermore, we have planned exploratory reanalysis of EGFR mutation status and screening of K-ras mutation status by the Scorpion Arms method which is also highly sensitive method among patients whose samples are available for analysis.

Patients and methods

Major eligibility criteria were advanced NSCLC with EGFR-wild type (gene analysis by PNA-LNA PCR clamp method), previously treated with one or two chemotherapy, and ECOG performance status (PS) of 0-2. Oral erlotinib 150mg was given daily until progression or unacceptable toxicity. The primary objective of the study was objective response rate. Secondary objectives were tolerability, progression-free survival, overall survival, verification of the concordance of EGFR mutation detection between the PNA-LNA PCR clamp method and Scorpion ARMS method, and screening K-ras mutation status by Scorpion ARMS methods. As of April 2012, enrollment of 55 patients has been completed. The study is in progress and we are planning data cut-off for efficacy and safety analysis in August 2012. (Unique trial Number; UMIN000002692)


H. Taniguchi: Hiroyuki Taniguchi has served as a member of advisory boards for Boehringer-Ingelheim, Chugai-Pharma, Shionogi & Co. Ltd.

H. Saito: Hiroshi Saito received research funding from Chugai Pharmaceuticals.

Y. Hasegawa: Yoshinori Hasegawa received research funding from Chugai Pharmaceuticals.

All other authors have declared no conflicts of interest.